COVIDIEN – $99,445.00/Year

Complete Requirements for the position are as follows Masters degree in Technology Management, Mechanical, Electrical, Industrial, or Biomedical Engineering or related field and two 2 years of experience as a Quality Engineer or in Quality Engineering. Experience must include a minimum of two 2 years of each of the following Quality Engineering for medical device components meeting specifications; 21 CFR Part 820 Quality System Regulation QSR, ISO 13485, European Union EU Medical Device Regulation MDR, State of the Art SOTA and Good Manufacturing Practices GMP; Risk Assessments, Preliminary Hazard Analysis PHA and PFMEA; NonConformances, Complaints and Corrective and Preventive Actions CAPA; Process Improvement Tool DMAIC, Root Cause Analysis, 5Whys, Fishbone and cause mapping; Design of Experiments DOE methods to establish process development; and Development of VV verification and validation, IQ, OQ, and PQ.